The following data is part of a premarket notification filed by Coopersurgical, Inc with the FDA for Air Bubble Based Infuser (abbi).
| Device ID | K143415 |
| 510k Number | K143415 |
| Device Name: | Air Bubble Based Infuser (ABBI) |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CooperSurgical, Inc 95 Corporate Dr. Trumbull, CT 06611 |
| Contact | James Keller |
| Correspondent | Chris Henza Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, WI 53158 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2015-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937014183 | K143415 | 000 |
| 00888937014174 | K143415 | 000 |